Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Public ClinicalTrials.gov record NCT07903675. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Autism spectrum disorder (ASD) is a developmental condition that can affect communication, social interaction, and behavior. Identifying ASD early helps children and families access support services sooner. Pupillometry is a way of measuring the nervous system and brain function by recording the pupil response to light. It is a non-invasive technology that may support screening practices by providing health care providers with an objective physical measure to bolster behavioral screening tools used to identify children with ASD . This study is evaluating how well the APS Detect™ handheld pupillometer works to help screen for ASD in children 2 to 4 years of age during routine pediatric healthcare visits. This investigational device measures the child's pupil response to light and uses these measurements to estimate the likelihood of ASD. Researchers will compare screening results using the APS Detect with the results of reference standard clinical assessments used to determine whether a child has autism. The study will assess how accurately the device identifies children with autism compared to children with typical development based on the Autism Pupil Screen (APS) score. The study will also evaluate whether the device provides the same results when used by different healthcare professionals. Information collected during this study will be used to evaluate device performance, safety, and suitability for use in pediatric healthcare settings and may support future review by the U.S. Food and Drug Administration (FDA).
Study identification
- NCT ID
- NCT07903675
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 330 participants
Conditions and interventions
Conditions
Interventions
- Autism Pupil Screen (APS) Detect PLR Assessment #1 Device
- Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F) Other
- Social Responsiveness Scale, Second Edition (SRS-2) Other
- Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) Diagnostic Test
- Mullen Scales of Early Learning (MSEL) Other
- Adaptive Behavior Assessment System, Third Edition (ABAS-3) Other
- Autism Pupil Screen (APS) Detect PLR Assessment #2 Device
- Autism Pupil Screen (APS) Detect Assessment #3 Device
- Well-child check Procedure
Device · Other · Diagnostic Test + 1 more
Eligibility (public fields only)
- Age range
- 24 Months to 60 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 23, 2026 (Actual)
- Primary completion
- Apr 16, 2027 (Estimated)
- Completion
- Apr 30, 2027 (Estimated)
- Last update posted
- Oct 29, 2026
2026 – 2027
United States locations
- U.S. sites
- 4
- U.S. states
- 2
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SEL Health Clinic - Lewiston | Lewiston | Idaho | 83501 | Recruiting |
| Palouse Pediatrics | Moscow | Idaho | 83843 | Recruiting |
| Palouse Pediatrics | Pullman | Washington | 99163 | Recruiting |
| SEL Health Clinic - Pullman | Pullman | Washington | 99163 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07903675, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 29, 2026 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07903675 live on ClinicalTrials.gov.